01-22550 gottlieb

January 2008Stop the War on DrugsBy Scott Gottlieb, M.D.In December 2005, Eli Lilly pled guilty to a criminal indictment from the Justice Department and paid$36 million in fines and “disgorgement” of its ill-gotten gains. The company’s crime was mounting aconcerted effort to inform doctors that, according to leading medical authorities, the firm’s estrogen-mod-ulating drug Evista substantially reduced the risk of invasive breast cancer in postmenopausal women.On the Issues
The finding came from a series of landmark
are sharing is part of educational meetings, peer-
national studies, some eventually touted by gov-
reviewed journal articles, or treatment guidelines
ernment research. So why the criminal charge?
issued by medical-specialty societies and govern-
At the time Eli Lilly was conveying the cancer
information to doctors, the Food and Drug
The prosecutions are aimed at recouping federal
Administration (FDA) had approved Evista for
money. The argument is that the medical commu-
treating osteoporosis, not preventing cancer.
nity is goaded by the drug companies into filing
Only this past September—eight years after the
“false claims” with the government, and hospitals
first significant cancer prevention results were
and health plans charge Medicare and Medicaid
published—did the FDA approve Evista for use
for drugs used for unapproved indications.
against breast cancer, turning Eli Lilly’s crime, by
Drug firms tend to settle these cases. Firms
some measures, into a public service.
have good reason to cut a deal: if they fight and
For patients and doctors who rely on the latest
lose in court, they can be banned from doing any
clinical information to make hard decisions, no
business with government programs like Medicare.
relevant scientific discovery took place between
At one time, prosecutions were aimed at a hand-
the medical findings, the legal prosecution, and
ful of bad actors that encouraged prescriptions for
the FDA’s approval of those same results. In fast-
purposes far outside popular medical practice. But
moving fields like cancer, in which doctors tailor
like a lot of government efforts, the scope of these
treatments based on evidence that is constantly
prosecutions expanded to encompass a much
evolving, two years can be an eternity to learn
about important science. For some patients, that
The Justice Department rarely alleges in these
cases that the scientific information is false or
At issue is what is referred to as “off-label
misleading, only that a firm can be “ahead of the
promotion”—allegations that drug companies
science” in sharing information with doctors
encourage doctors to use medicines for purposes
about emerging uses of medicines, even when
not yet approved by the FDA. These charges are
those new uses quickly become the mainstay of
applied even when the information drug firms
care. Underlying this, of course, is a nagging pre-sumption that doctors cannot be trusted to weigh
Scott Gottlieb, M.D., is a resident fellow at AEI. A
for themselves this sort of medical information
version of this article appeared in the Wall Street Journalon December 17, 2007.
and thus need the FDA’s supervision.
1150 Seventeenth Street, N.W., Washington, D.C. 20036
This might be more tolerable in a world where the
question: just who is in the best position to make these
FDA rapidly adjudicates study results to decide what
belongs in and out of drug labels. In reality, the FDA
The travails of another Genentech drug, the breast
reserves ten months to consider supplemental uses for
cancer medicine Herceptin, demonstrate the health con-
marketed drugs, and the entire process usually is much
sequences of these prosecutions. Herceptin was widely
longer. In many cases, doctors do not easily learn about
used in advanced breast cancers for years, and recently
these new drug uses or get targeted education on pre-
it was found to cut recurrence by about half in some
scribing without the help of the drug firm, which is the
patients with earlier-stage tumors. The results were first
only deep-pocketed actor with an incentive to share
published early in 2005, and the new use was approved
by the FDA in late 2006. The wider use of Herceptinwill save lives, but doctors did not embrace it right away.
Herceptin prescriptions spiked when the study was
first published in the New England Journal of Medicine,
only to tail off before spiking again at the time of FDAapproval. Those early adopters were probably familiar
with the drug and the findings, perhaps through practic-
ing in busy academic centers. Some of the late adoptersmight have been reluctant to take up the new use with-
half of cancer medicine is practiced.
out the benefit of targeted education. You can bet thatfolks at Genentech, living under the thumb of the
The Philadelphia U.S. attorney’s office has conducted
Philadelphia U.S. attorney, were not about to talk up the
a multiyear investigation into the biotech company
Genentech. They are alleging that meetings the company
The use of Herceptin in early-stage breast cancers
sponsored for oncologists in the 1990s were illegal—
was roughly half what you would expect for the almost
because Genentech shared information about unapproved
two years between publication of the study’s findings
uses for its drug Rituxan, used largely in the treatment
and the FDA nod. It is hard to deny that some of those
of lymphoma. Nevermind that the forms of lymphoma
Herceptin-eligible women who did not get the drug are
for which Rituxan was to be used were largely fatal; that
some of those uses are now approved by the FDA; and
Attorney General Michael Mukasey could add to the
that the education was based on findings from large
staff manual for his attorneys a requirement that they
studies, including one supported by the government. In
merely check with a public health authority like the
fact, if you queried the National Cancer Institute’s
National Institutes of Health to see if a certain off-label
website—even at the time when Genentech allegedly
use falls within the scope of appropriate medical care
engaged in the illegal educational activity—for advice
before waging a legal war. Even that may be a hard sell
on the best treatments for some of these same forms of
in Washington, where prosecutions are pursued on the
lymphoma, the search returned “Rituxan.”
basis of how much money they can recoup.
“Off-label” is now a dirty term in the conventional
lexicon, made synonymous with lawbreaking as a result
(D-Calif.) took umbrage at a copy of a draft FDA guid-
of these prosecutions, even though it describes the way
ance (he leaked it himself), saying that, as a public
more than half of cancer medicine is practiced. It is true
health matter, the FDA found it appropriate for drug
that some off-label drug use is based on very unsettled
firms to share study reprints from peer-reviewed medical
science and has more risks. But medicine—and not just
journals. Drug firms are personae non gratae in Washing-
cancer care—involves lots of hard choices. And the
ton, a result of the industry’s own excesses but also of a
more serious the disorder, often the more likely it is that
lot of political targeting. The result is an anything-that-
for every right and wrong treatment choice there are
bashes-pharma-goes mentality in policymaking.
many other practical decisions painted in shades of gray.
Politicians wage broad wars on medicine to claim thin
Efforts to confine patients and doctors to FDA-approved
strips of ideological terrain. This would be good political
uses have their own health consequences, raising the
theater if there were not so many human victims.

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